AccessGUDID - DEVICE: MSI (00810130206483)

GUDID

Device Identifier (DI) Information

Brand Name: MSI
Version or Model: 777-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Modern Surgical Instruments LLC

Primary DI Number: 00810130206483
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118447158 *Terms of Use

Device Description: Basic M-Style Set includes:968-74 Small Tray w/ Lid (243mm x 253mm x 50mm), UDI 00810130201648 777-05 Hinged Retractor, Max Opening: 85mm, Ti., UDI 00810130201389 778-10 Narrow Muscle Blade, 20mm Width x 40mm Depth, Ti., UDI 00810130201419 778-15 Narrow Muscle Blade, 20mm Width x 50mm Depth, Ti., UDI 00810130201426 778-20 Narrow Muscle Blade, 20mm Width x 60mm Depth, Ti., UDI 00810130201433 778-25 Narrow Muscle Blade, 20mm Width x 70mm Depth, Ti., UDI 00810130201440 778-60 Wide Muscle Blade, 27 mm Width x 40mm Depth, Ti., UDI 00810130201471 778-65 Wide Muscle Blade, 27 mm Width x 50mm Depth, Ti., UDI 00810130201488 778-70 Wide Muscle Blade, 27 mm Width x 60mm Depth, Ti., UDI 00810130201495 778-75 Wide Muscle Blade, 27 mm Width x 70mm Depth, Ti., UDI 00810130201501 779-60 Multiple Toothed Hook, 30mm, Ti., UDI 00810130201532 779-65 Multiple Toothed Hook, 40mm, Ti., UDI 00810130201549 779-70 Multiple Toothed Hook, 50mm, Ti., UDI 00810130201556 779-75 Multiple Toothed Hook, 60mm, Ti., UDI 00810130201563 779-10 Hook Blade, 30mm, Ti, UDI 00810130201594 779-15 Hook Blade, 40mm, Ti, UDI 00810130201600 779-20 Hook Blade, 50mm, Ti, UDI 00810130201617 779-25 Hook Blade, 60mm, Ti, UDI 00810130201624

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45182	Self-retaining surgical retractor, reusable	A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFO	Retractor, Self-Retaining

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a10d5e64-5c71-4756-aaad-c90fb0d2c2de
Public Version Date: May 27, 2025
Public Version Number: 1
DI Record Publish Date: May 19, 2025