Collins Speculum Large 030948

GUDID M803030948

Collins Speculum Large 1 5/8" x 4 1/2" (41mm x 114mm)

MEDGYN PRODUCTS, INC.

Vaginal speculum, reusable

• Primary Device ID: M803030948
• NIH Device Record Key: d37949c7-c980-46a5-9a25-6b518a5dd394
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Collins Speculum Large
• Version Model Number: Collins Speculum Large 1 5/8" x 4 1/2" (41mm x 11
• Catalog Number: 030948
• Company DUNS: 103913430
• Company Name: MEDGYN PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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
HIBCC	M803030948 [Primary]

FDA Product Code

• HDF: Speculum, Vaginal, Metal

Sterilization

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

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

[M803030948]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-03
• Device Publish Date: 2025-05-26

Devices Manufactured by MEDGYN PRODUCTS, INC.

• M803030100 - Rotating Shaft (w/any tip): 2025-06-09 Rotating Shaft (w/any tip)
• M803030148 - Rotating Shaft - Tischler Tip - Down: 2025-06-09 Rotating Shaft - Tischler Tip - Down
• M803040060 - Repaired Products: 2025-06-09 Repaired Products
• M8030030976 - Graves Vu-Max Large: 2025-06-03 Graves Vu-Max Large 5" (127mm)
• M803030906 - Pederson Small: 2025-06-03 Pederson Small 1/2" x 3" (13mm x 76mm)
• M803030907 - Pederson Medium: 2025-06-03 Pederson Medium 7/8" x 4" (22mm x 102mm)
• M803030908 - Pederson Large: 2025-06-03 Pederson Large 1" x 4 3/4" (25mm x 121mm)
• M803030910 - Graves Wide Angled Medium Right Side Open: 2025-06-03 Graves Wide Angled Medium Right Side Open 1 3/8" x 4" (35mm x 102mm)