AccessGUDID - DEVICE: Sklar® (10649111121050)

GUDID

Device Identifier (DI) Information

Brand Name: Sklar®
Version or Model: 11-1295
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SKLAR CORPORATION

Primary DI Number: 10649111121050
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006966006 *Terms of Use

Device Description: BRUNS PLASTER SHEARS SER 9 1/4

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):	No
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?
46314	Cast cutting scissors	A hand-held surgical instrument with specially strong, curved blades that is used to cut small plaster cast dressings and layers of thick material, e.g., bandages. It is designed like a strong pair of scissors with two pivoted blades usually provided with finger and thumb holes in the handles. The distal end of the blades may be different shapes and are usually rounded or have a pod at the tip for safety. The longest blade is inserted between the body surface and the plaster cast and pressure is exerted upon the handles by squeezing them together to create the cutting effect. It is typically made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGG	INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL

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: fccc575a-9d11-482a-89dd-be44d1a32e0d
Public Version Date: February 04, 2019
Public Version Number: 1
DI Record Publish Date: January 04, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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