AccessGUDID - DEVICE: Sephure® suppository applicator (00868648000000)

GUDID

Device Identifier (DI) Information

Brand Name: Sephure® suppository applicator
Version or Model: A2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Cristcot LLC

Primary DI Number: 00868648000000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080739421 *Terms of Use

Device Description: A2 - rectal suppository applicator (individually wrapped)

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?
61327	Rectal medication applicator, single-use	A non-sterile instrument intended to be inserted into the rectum for the application of medication to treat local or systemic disease/conditions. It is a plastic device which may be in the form of a short tube to be connected to a cream medication tube, or a fluted tube with a plunger to administer a suppository. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOW	Applicator For Rectal Suppository

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092829	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: ac9896d6-939b-4b2d-9117-ce2ddeb90a28
Public Version Date: October 06, 2021
Public Version Number: 1
DI Record Publish Date: September 28, 2021

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

Customer Contact

[?]

Phone: 978-212-6380
Email: info@sephure.com

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