FDA.reportPublic FDA data

SURGICEL SNoW

Primary DI
10705031063617
Brand
SURGICEL SNoW
Company
ETHICON, LLC
Model
2091
Catalog number
2091
Device description
Surgicel Absorbable Hemostat, Structured Non-Woven Fabric
Published
2014-09-20
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
N12159032

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
N12159032SURGICEL BRAND ABSORBABLE HEMOSTATETHICON, Inc.1960-10-14LMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031063614PackageGS110In Commercial Distribution
10705031063617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503106361420705031063614
1070503106361710705031063617

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 Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
829465157
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031002449MERSILENE1762G1762G2015-09-01
10705031002401MERSILENE1760G1760G2015-09-01
10705031009547MERSILENE740G740G2015-09-01
10705031045040PERMA-HANDM13TM13T2015-09-01
10705031047259NUROLONN104TN104T2015-09-01
10705031047273NUROLONN124TN124T2015-09-01
10705031049499MERSILENER495TR495T2015-09-01
10705031049642MERSILENER756GR756G2015-09-01
10705031050006PERMA-HANDSA10GSA10G2015-09-01
10705031050037PERMA-HANDSA5HSA5H2015-09-01
10705031050129PERMA-HANDSA6HSA6H2015-09-01
10705031050143PERMA-HANDSA73HSA73H2015-09-01
10705031050167PERMA-HANDSA74HSA74H2015-09-01
10705031050181PERMA-HANDSA75HSA75H2015-09-01
10705031050204PERMA-HANDSA76GSA76G2015-09-01
10705031050228PERMA-HANDSA77GSA77G2015-09-01
10705031050242PERMA-HANDSA7HSA7H2015-09-01
10705031050310PERMA-HANDSA8HSA8H2015-09-01
10705031050358PERMA-HANDSA9GSA9G2015-09-01
10705031023369PERMA-HANDC004DC004D2015-09-01

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
10705031002968SURGICEL 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