ENDO-SPIKE 491403000

GUDID 04055207050279

NEEDLES FOR STITCHING FORCEPS for ENDO-SPIKE 891403000, PACK = 5 PCS, sterile, for single use

Richard Wolf GmbH

General-purpose endoscopic needle, single-use

• Primary Device ID: 04055207050279
• NIH Device Record Key: d2ce969b-d376-4902-aed3-b14edaa199ae
• Commercial Distribution Discontinuation: 2023-09-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ENDO-SPIKE
• Version Model Number: 491403000
• Catalog Number: 491403000
• Company DUNS: 315304071
• Company Name: Richard Wolf GmbH
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com
• Phone: +497043350
• Email: info@richard-wolf.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04055207049150 [Primary]
GS1	04055207050279 [Unit of Use]

FDA Product Code

• NBH: Accessories, arthroscopic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

[04055207050279]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-22
• Device Publish Date: 2022-11-01

Devices Manufactured by Richard Wolf GmbH

• 04055207068243 - VERTEBRIS: 2026-02-18 KNOT PUSHER Ø 2.5MM WL 330MM reusable
• 04055207069691 - NA: 2026-02-18 CAGE SLEEVE ID 15MM OD 16 mm, TL 145 mm, reusable
• 04055207069707 - NA: 2026-02-18 CAGE SLEEVE SQUARE ID 15MM OD 16 mm, TL 145 mm, reusable
• 04055207069714 - NA: 2026-02-18 CAGE SLEEVE SQUARE ID 13.6MM OD 14,6 mm, TL 145 mm, reusable
• 04055207069721 - NA: 2026-02-18 CAGE SLEEVE ID 13.6MM OD 14,6 mm, TL 145 mm, reusable
• 04055207069738 - NA: 2026-02-18 DILATOR SQUARE ID 9.5MM OD 14.9MM TL 210 mm, reusable
• 04055207069745 - NA: 2026-02-18 DILATOR SQUARE ID 9.5MM OD 13.5MM TL 210 mm, reusable
• 04055207069790 - NA: 2026-01-22 KERRISON SHEATH W 5MM CURVED 40° for use with Kerrison handle, WL 130 mm, reusable