AccessGUDID - DEVICE: SUPPORT TRAY (00858965006823)

GUDID

Device Identifier (DI) Information

Brand Name: SUPPORT TRAY
Version or Model: TDLU236
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: PAJUNK MEDICAL SYSTEMS, LP

Primary DI Number: 00858965006823
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 136718553 *Terms of Use

Device Description: Custom Support Tray

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
66346	Local/regional anaesthesia support kit	A collection of noninvasive devices intended to support a local and/or regional anaesthesia procedure (e.g., spinal/epidural anaesthesia, peripheral nerve block). It includes supportive devices such as drapes, bowls, towels, and dressing forceps; neither a needle, anaesthesia catheter, nor medication is included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OGD	Custom Anesthesia Tray

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 70707fc0-8488-4fcc-8501-1edce214a41d
Public Version Date: October 23, 2023
Public Version Number: 1
DI Record Publish Date: October 13, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50858965006828	25	00858965006823		In Commercial Distribution	N/A

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: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 770-493-6832
Email: info@pajunk-usa.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES