FDA.report

OTS - Joint Safety Institute Field Kit

Primary DI
00766588160771
Brand
OTS - Joint Safety Institute Field Kit
Company
Certified Safety Manufacturing, Inc.
Model
K616-077
Catalog number
K616-077
Device description
OTS - Joint Safety Institute Field Kit
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
00766588160771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00766588160771007665881607717665881607710766588160771

GMDN Terms

TermDefinition
Eye padA cushion-like device made of various materials (e.g., gauze, cotton) intended to protect the eye or to absorb eye secretions. 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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