FDA.report

E-PACK

Primary DI
30705031242009
Brand
E-PACK
Company
ETHICON INC.
Model
9698E
Catalog number
9698E
Device description
E-Pack Procedure Kit
Published
2017-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Product Code Classifications

CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30705031242009PackageGS15In Commercial Distribution
20705031242002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3070503124200930705031242009
2070503124200220705031242002

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Away from moisture and direct heat
Storage Environment Temperature025 Degrees Celsius
Storage Environment Temperature077 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags

DUNS number
002144145
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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