Realstar Sugical

GUDID 00860012999668

Pederson Vaginal Speculum, Medium

REAL STAR SURGICAL INSTRUMENTS

Vaginal speculum, reusable

• Primary Device ID: 00860012999668
• NIH Device Record Key: cf6e1f07-cd01-4c60-bde9-2ade4b9072d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Realstar Sugical
• Version Model Number: RSSI-130-202
• Company DUNS: 645842282
• Company Name: REAL STAR SURGICAL 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012999668 [Primary]

FDA Product Code

• HDF: Speculum, Vaginal, Metal

Sterilization

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

[00860012999668]

Moist Heat or Steam Sterilization

[00860012999668]

Moist Heat or Steam Sterilization

[00860012999668]

Moist Heat or Steam Sterilization

[00860012999668]

Moist Heat or Steam Sterilization

[00860012999668]

Moist Heat or Steam Sterilization

[00860012999668]

Moist Heat or Steam Sterilization

[00860012999668]

Moist Heat or Steam Sterilization

[00860012999668]

Moist Heat or Steam Sterilization

[00860012999668]

Moist Heat or Steam Sterilization

[00860012999668]

Moist Heat or Steam Sterilization

[00860012999668]

Moist Heat or Steam Sterilization

[00860012999668]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-20
• Device Publish Date: 2025-01-12

Devices Manufactured by REAL STAR SURGICAL INSTRUMENTS

• 00850071684162 - Realstar Surgical: 2025-01-29 Schroeder Tenaculum(Insulated Tips)
• 00850071684179 - Realstar Surgical: 2025-01-29 Iris Hook
• 00850071684186 - Realstar Surgical: 2025-01-29 Atraumatic Tenaculum
• 00850071684193 - Realstar Surgical: 2025-01-29 Straight Hook
• 00850071684209 - Realstar Surgical: 2025-01-29 Two-Prong Hook
• 00850071684216 - Realstar Surgical: 2025-01-29 Three-Prong Hook
• 00850071684223 - Realstar Surgical: 2025-01-29 Ring Forceps
• 00850071684230 - Realstar Surgical: 2025-01-29 Kogan Endocervical Speculum, 5mm