FDA.report

Pak-Its™

Primary DI
00809958040416
Brand
Pak-Its™
Company
Derma Sciences Canada Inc
Model
4868
Catalog number
DUP4868
Device description
4 in X 36 in 4 ply Strung Surgical Gauze. X-Ray detectable.
Published
2018-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GDYGAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00809958040416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00809958040416008099580404168099580404160809958040416

GMDN Terms

TermDefinition
Gauze stripA thin length of non-medicated sterile woven material (e.g., cotton, cellulose) primarily designed to pack draining wounds to absorb exudates; it does not include an antimicrobial agent. It may be soaked with medication (not included) before application. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
200564891
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

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30381780491730PETROLATUM GAUZE®20059DKC200592018-10-23
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30381780491853PrimaDerm®69101DUP691012018-10-23
30381780491884Pak-its®59145DUP591452018-10-23
30381780491891Pak-its®59146DUP591462018-10-23
30381780491907Pak-its®59245DUP592452018-10-23
30381780491914Pak-its®59246DUP592462018-10-23
30381780491921Pak-its®59345DUP593452018-10-23
30381780491938Pak-its®59346DUP593462018-10-23

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