AccessGUDID - DEVICE: Skytrofa Auto-Injector (05713495000077)

GUDID

Device Identifier (DI) Information

Brand Name: Skytrofa Auto-Injector
Version or Model: 1002247
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Phillips-Medisize A/S

Primary DI Number: 05713495000077
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 306047440 *Terms of Use

Device Description: No description.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
45819	Empty self-injector, electronic	A portable, hand-held, battery-powered device, commonly referred to as an electronic autoinjector, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient or carer for subcutaneous or intramuscular injection of a dose of the pharmaceutical agent via a replaceable needle. The device includes an electronic display and may be capable of a variety of dose-recording functions. The needle is replaced for each administration. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZH	Introducer, Syringe Needle

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: 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: 30303305-0891-4975-9f3f-2d55c0e2376b
Public Version Date: April 18, 2025
Public Version Number: 3
DI Record Publish Date: October 22, 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
05713495000084	10	05713495000077		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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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