AccessGUDID - DEVICE: Surgilube (00851809002463)

GUDID

Device Identifier (DI) Information

Brand Name: Surgilube
Version or Model: 281020555
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 281020555
Company Name: HR PHARMACEUTICALS INC.

Primary DI Number: 00851809002463
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828918164 *Terms of Use

Device Description: Sterile Surgical Lubricant, Metal Tube

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":	No
For Single-Use:	Yes
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?
60796	General-body orifice lubricant	A substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.	Active	false
60795	Multi-purpose surgical instrument lubricant	A sterile substance intended to be applied to a sterile surgical instrument prior to use for device mechanical and patient lubrication purposes (e.g., to facilitate moving parts of device, and to facilitate movement between instrument and patient); it is not dedicated to a specific type of surgical instrument. It includes plant-derived materials (e.g., glycerin) and may also be intended for non-surgical applications (e.g., entry of a device into a body orifice). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMJ	Lubricant, patient

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: Yes

Sterilization Method [?]
Liquid Chemical

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 5 Gram

Device Record Status

Public Device Record Key: 0cb0fdd6-53bb-49fb-af97-7408137d5c5b
Public Version Date: June 17, 2024
Public Version Number: 3
DI Record Publish Date: August 27, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
30851809002464	4	20851809002467	In Commercial Distribution	Case
20851809002467	3	10851809002460	In Commercial Distribution	Carton
10851809002460	48	00851809002463	In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
NDC/NHRIC	00281020555

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: +1(717)252-1110 ext: 109
Email: chris.wiesman@hrpharma.com

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

FDA TOOLS & RESOURCES