FDA.reportPublic FDA data

SURGICEL NU-KNIT

Primary DI
10705031002968
Brand
SURGICEL NU-KNIT
Company
Ethicon Sàrl
Model
1941
Catalog number
1941
Device description
Absorbable Hemostat (oxidized regenerated cellulose)
Published
2016-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LMGAgent, absorbable hemostatic, non-collagen based

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMGAgent, Absorbable Hemostatic, Non-Collagen BasedGeneral, Plastic Surgery3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
N12159000
N12159014
N12159082
N12159083
N12159086
N12159087
N12159090

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
N12159000SURGICEL BRAND ABSORBABLE HEMOSTATETHICON, Inc.1960-10-14LMG
N12159014SURGICEL BRAND ABSORBABLE HEMOSTATETHICON, Inc.1960-10-14LMG
N12159082SURGICEL BRAND ABSORBABLE HEMOSTATETHICON, Inc.1960-10-14LMG
N12159083SURGICEL BRAND ABSORBABLE HEMOSTATETHICON, Inc.1960-10-14LMG
N12159086SURGICEL BRAND ABSORBABLE HEMOSTATETHICON, Inc.1960-10-14LMG
N12159087SURGICEL BRAND ABSORBABLE HEMOSTATETHICON, Inc.1960-10-14LMG
N12159090SURGICEL BRAND ABSORBABLE HEMOSTATETHICON, Inc.1960-10-14LMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031002965PackageGS110In Commercial Distribution
10705031002968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503100296520705031002965
1070503100296810705031002968

GMDN Terms#

Term, Definition table
TermDefinition
Plant polysaccharide haemostatic agent, bioabsorbableA bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound to facilitate local haemostasis; it is not dedicated to bone haemostasis. It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. It may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature086 Degrees Fahrenheit
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
480920383
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031062306GYNECARE TVT810081L810081L2015-09-23
10705031062368GYNECARE TVT ABBREVOTVTOMLTVTOML2015-09-23
10705031062375GYNECARE TVT EXACTTVTRLTVTRL2015-09-23
10705031000346GYNECARE TVT8100818100812015-09-23
10705031002999SURGICEL NU-KNIT194619462014-09-20
10705031003118SURGICEL FIBRILLAR196119612014-09-20
10705031003125SURGICEL FIBRILLAR196219622014-09-20
10705031003132SURGICEL FIBRILLAR196319632014-09-20
10705031005396GYNECARE INTERCEED435043502014-09-20
10705031468092SURGICEL NU-KNIT1943S1943S2023-05-15
10705031468108SURGICEL1951S1951S2023-05-15
10705031468115SURGICEL1952S1952S2023-05-15
10705031468122SURGICEL1953S1953S2023-05-15
10705031468139SURGICEL1955S1955S2023-05-15
10705031468085SURGICEL NU-KNIT1940S1940S2023-07-28
10705031002951SURGICEL NU-KNIT194019402016-10-19
30705031468089SURGICEL NU-KNIT1940S1940S2023-07-28
10705031003019SURGICEL195119512014-09-20
10705031003026SURGICEL195219522014-09-20
10705031003033SURGICEL195319532014-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031468085SURGICEL NU-KNITEthicon SàrlLMG2023-07-28
30705031468089SURGICEL NU-KNITEthicon SàrlLMG2023-07-28
05413765891380PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
05413765891335PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
05413765891366PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
05413765891373PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
75413765891389PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
05413765891397PerClotBAXTER HEALTHCARE CORPORATIONLMG2023-06-23
10705031468092SURGICEL NU-KNITEthicon SàrlLMG2023-05-15
10705031468108SURGICELEthicon SàrlLMG2023-05-15
10705031468115SURGICELEthicon SàrlLMG2023-05-15
10705031468122SURGICELEthicon SàrlLMG2023-05-15
10705031468139SURGICELEthicon SàrlLMG2023-05-15
30705031468096SURGICEL NU-KNITEthicon SàrlLMG2023-05-15
30705031468102SURGICELEthicon SàrlLMG2023-05-15
30705031468119SURGICELEthicon SàrlLMG2023-05-15
30705031468126SURGICELEthicon SàrlLMG2023-05-15
30705031468133SURGICELEthicon SàrlLMG2023-05-15
10705031237513SURGICELETHICON, LLCLMG2019-05-13
20705031237510SURGICELETHICON, LLCLMG2019-05-13
10705031237506ETHICONETHICON, LLCLMG2017-08-31
10705031002951SURGICEL NU-KNITEthicon SàrlLMG2016-10-19
20705031002958SURGICEL NU-KNITETHICON, LLCLMG2016-10-19
20705031002965SURGICEL NU-KNITETHICON, LLCLMG2016-10-19
00851772007014Emergency Medical ProductsEMERGENCY MEDICAL PRODUCTS, INC.LMG2016-09-24
00851772007069Emergency Medical ProductsEMERGENCY MEDICAL PRODUCTS, INC.LMG2016-09-24
00851772007144Emergency Medical ProductsEMERGENCY MEDICAL PRODUCTS, INC.LMG2016-09-24
00851772007168Emergency Medical ProductsEMERGENCY MEDICAL PRODUCTS, INC.LMG2016-09-24
00851772007175Emergency Medical ProductsEMERGENCY MEDICAL PRODUCTS, INC.LMG2016-09-24
00851772007281Emergency Medical ProductsEMERGENCY MEDICAL PRODUCTS, INC.LMG2016-09-24