FDA.report

Coated VICRYL

Primary DI
30705031470495
Brand
Coated VICRYL
Company
ETHICON, LLC
Model
JJ40D
Catalog number
JJ40D
Device description
Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture
Published
2023-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
30705031470495PackageGS112In Commercial Distribution
10705031470491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3070503147049530705031470495
1070503147049110705031470491

GMDN Terms

TermDefinition
Polyester suture, bioabsorbable, multifilament, non-antimicrobialA multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
079402290
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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30705031097234PROLENEEH7583HEH7583H2025-11-11
30705031098439PROLENEEH7835HEH7835H2025-11-11
30705031116201PROLENEF1880F18802025-11-11
30705031098477PROLENEEH7897GEH7897G2025-04-22
30705031228348PROLENEEP8729HEP8729H2025-04-22
30705031228621PROLENEEP8767HEP8767H2025-04-22
30705031237807PROLENEW753GW753G2025-04-22
30705031050864ETHICONTPW10TPW102015-09-24
10705031050877ETHICONTPW20TPW202015-09-01
10705031050884ETHICONTPW30TPW302015-09-01
10705031050891ETHICONTPW32TPW322015-09-01

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