AccessGUDID - DEVICE: Sklar® (10649111144004)

GUDID

Device Identifier (DI) Information

Brand Name: Sklar®
Version or Model: 78-3528
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SKLAR CORPORATION

Primary DI Number: 10649111144004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006966006 *Terms of Use

Device Description: JACKSON TRACH HOOK DE 7"

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?
35112	Tracheal hook	A double-ended surgical instrument designed to hold the trachea steady during the creation of a tracheostoma and/or for separating/drawing aside the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. It can be of various designs, e.g., double or single-ended with one end forming a broad bladed retractor and the opposite end tapers to form a pointed hook formed at various angles or multiple parallel hooks. It is made of high-grade stainless steel. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KCH	HOOK, TRACHEAL

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: 86002830-b37b-43fb-b485-95846896a44a
Public Version Date: December 03, 2018
Public Version Number: 1
DI Record Publish Date: October 31, 2018

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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