AccessGUDID - DEVICE: STINGRAY SURGICAL PRODUCTS (B112G74045I0)

GUDID

Device Identifier (DI) Information

Brand Name: STINGRAY SURGICAL PRODUCTS
Version or Model: G74-045I
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G74-045I
Company Name: STINGRAY SURGICAL PRODUCTS L.L.C.

Primary DI Number: B112G74045I0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024328124 *Terms of Use

Device Description: Desmarres Lid Retractor Insulated, Double Ended, 8mm/10mm, Length 6.0" (15.2cm), Stainless Steel

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":	Yes
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?
45918	Hand-held surgical retractor, reusable	A hand-held, non-self-retaining 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 dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEG	Elevator, Surgical, General & Plastic Surgery

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: 73b78c48-084e-461a-853f-ad26b9026d34
Public Version Date: August 07, 2024
Public Version Number: 2
DI Record Publish Date: May 19, 2021