AccessGUDID - DEVICE: Sklar Instruments (10649111448607)

GUDID

Device Identifier (DI) Information

Brand Name: Sklar Instruments
Version or Model: 96-2243M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SKLAR CORPORATION

Primary DI Number: 10649111448607
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006966006 *Terms of Use

Device Description: ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
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?
65652	Multiple-type respiratory pathogen immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to multiple types of respiratory pathogens (e.g., viruses and bacteria) in a clinical specimen, using a fluorescent immunoassay method. Organisms intended to be detected may include Legionella pneumophila, Mycoplasma pneumoniae, Coxiella burnetiid, Chlamydophila pneumoniae, respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, and/or adenovirus.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	RETRACTOR

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: a59e85cb-4579-4a08-9300-4fd19480e318
Public Version Date: February 12, 2025
Public Version Number: 2
DI Record Publish Date: January 02, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50649111448605	25	10649111448607		In Commercial Distribution

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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