FDA.report

E-PACK

Primary DI
30705031241316
Brand
E-PACK
Company
ETHICON INC.
Model
9850E
Catalog number
9850E
Device description
E-Pack Procedure Kit
Published
2018-04-05
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
GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Product Code Classifications

CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30705031241316PackageGS15In Commercial Distribution
20705031241319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3070503124131630705031241316
2070503124131920705031241319

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

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
002144145
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company

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20705031003306J-VAC216121612015-09-23
20705031003313J-VAC216221622015-09-23
20705031003320J-VAC216321632015-09-23
30705031078486Coated VICRYLVCP496ZHVCP496ZH2023-01-09
30705031470105Coated VICRYLVCP496ZGVCP496ZG2023-01-09
10705031228139ETHICONEVRC67EVRC672015-09-23
30705031078080Coated VICRYLVCP392ZHVCP392ZH2023-02-06
20705031003467BLAKE221022102015-09-23
20705031003474BLAKE221122112015-09-23
20705031003481BLAKE221222122015-09-23
20705031003498BLAKE221322132015-09-23
20705031003504BLAKE221422142015-09-23
20705031003511BLAKE221522152015-09-23
20705031003528BLAKE221622162015-09-23
20705031003535BLAKE221722172015-09-23
20705031003542BLAKE222622262015-09-23
20705031003559BLAKE222722272015-09-23
20705031003566BLAKE222822282015-09-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08903837747532Polypropylene sutureHEALTHIUM MEDTECH LIMITEDGAW2026-05-25
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03661522101919COROLENE®PETERS SURGICALGAW2026-03-06
03661522101926COROLENE®PETERS SURGICALGAW2026-03-06
03661522101933COROLENE®PETERS SURGICALGAW2026-03-06
03661522101940COROLENE®PETERS SURGICALGAW2026-03-06
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03661522101988COROLENE®PETERS SURGICALGAW2026-03-06
03661522101995COROLENE®PETERS SURGICALGAW2026-03-06
03661522102008COROLENE®PETERS SURGICALGAW2026-03-06
03661522102015COROLENE®PETERS SURGICALGAW2026-03-06
03661522102022COROLENE®PETERS SURGICALGAW2026-03-06
03661522102039COROLENE®PETERS SURGICALGAW2026-03-06
03661522102046COROLENE®PETERS SURGICALGAW2026-03-06
03661522102053COROLENE®PETERS SURGICALGAW2026-03-06
03661522102060COROLENE®PETERS SURGICALGAW2026-03-06
03661522102077COROLENE®PETERS SURGICALGAW2026-03-06
03661522102084COROLENE®PETERS SURGICALGAW2026-03-06
03661522102091COROLENE®PETERS SURGICALGAW2026-03-06
03661522102107COROLENE®PETERS SURGICALGAW2026-03-06
03661522102114COROLENE®PETERS SURGICALGAW2026-03-06
03661522102121COROLENE®PETERS SURGICALGAW2026-03-06
03661522102138COROLENE®PETERS SURGICALGAW2026-03-06
03661522102145COROLENE®PETERS SURGICALGAW2026-03-06
03661522102152COROLENE®PETERS SURGICALGAW2026-03-06
03661522102169COROLENE®PETERS SURGICALGAW2026-03-06
03661522102176COROLENE®PETERS SURGICALGAW2026-03-06
03661522102183COROLENE®PETERS SURGICALGAW2026-03-06
03661522102190COROLENE®PETERS SURGICALGAW2026-03-06