FDA.report

10PW - Hawaiian Telecom

Primary DI
00766588120683
Brand
10PW - Hawaiian Telecom
Company
Certified Safety Manufacturing, Inc.
Model
K612-068
Catalog number
K612-068
Device description
10PW - Hawaiian Telecom
Published
2022-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LRRFirst Aid Kit with drug

Product Code Classifications

CodeDeviceSpecialtyClass
LRRFirst Aid Kit With DrugUnknownN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00766588120683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588120683007665881206837665881206830766588120683

GMDN Terms

TermDefinition
Dressing-fixation skin adhesive tape, non-siliconeA long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(816)483-9090Info@certifiedsafety.com

Regulatory Flags

DUNS number
788460483
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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