PEDERSON SPECULUM MEDIUM SP104

GUDID G422SP1040

PEDERSON SPECULUM MEDIUM

BIOPSY FINE CUT INSTRUMENTS

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

• G422BP0110 - TISCHLER OVAL 21CM: 2024-10-11
• G422SP0030 - GRAVES VAG SPEC LG 4.5: 2024-10-11
• 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)