PEDERSON SPECULUM MEDIUM SP104

GUDID G422SP1040

PEDERSON SPECULUM MEDIUM

BIOPSY FINE CUT INSTRUMENTS

Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable Vaginal speculum, reusable

• Primary Device ID: G422SP1040
• NIH Device Record Key: 28e82e6f-20a4-453b-97a5-2a176cd620a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEDERSON SPECULUM MEDIUM
• Version Model Number: SP104
• Catalog Number: SP104
• Company DUNS: 645680898
• Company Name: BIOPSY FINE CUT INSTRUMENTS
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G422SP1040 [Primary]

FDA Product Code

• HDF: Speculum, Vaginal, Metal

Sterilization

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

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

[G422SP1040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-23
• Device Publish Date: 2023-10-13

Devices Manufactured by BIOPSY FINE CUT INSTRUMENTS

• G422BP0120 - TISCHLER KEVORKIAN BIOPSY PUNCH: 2023-12-06 TISCHLER KEVORKIAN BIOPSY PUNCH 8.25"
• G422BP0181 - TISCHLER MORGAN BIOPSY PUNCH 10": 2023-10-23 Size 10" Straight Made by stainless steel
• G422BP0191 - BABY TISCHLER BIOPSY PUNCH 10": 2023-10-23 Size 10" Made by Stainless Steel
• G422BP1091 - ROTO TISCHLER BIOPSY PUNCH 10": 2023-10-23 ROTO TISCHLER BIOPSY PUNCH 10" UP, COMPLETE SET HANDLE+TIP
• G422DL0030 - MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MM: 2023-10-23 MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MM
• G422DL1010 - DILATOR CERVICAL SET OF 6: 2023-10-23 DILATOR CERVICAL SET OF 6, (1-6MM)
• G422DL3000 - HANK DILATOR DOUBLE ENDED 7/8 FR: 2023-10-23 HANK DILATOR DOUBLE ENDED 7/8 FR
• G422DL3010 - HANK DILATOR SET OF 6 (Z304): 2023-10-23 HANK DILATOR SET OF 6 (Z304)