FDA.reportPublic FDA data

SURGICEL

Primary DI
30705031468102
Brand
SURGICEL
Company
Ethicon Sàrl
Model
1951S
Catalog number
1951S
Device description
Absorbable Hemostat (oxidized regenerated cellulose)
Published
2023-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
N12159000SURGICEL BRAND ABSORBABLE HEMOSTATETHICON, Inc.1960-10-14LMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031468102PackageGS112In Commercial Distribution
10705031468108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503146810230705031468102
1070503146810810705031468108

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
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
480920383
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

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
10705031002968SURGICEL NU-KNIT194119412016-10-19
10705031003019SURGICEL195119512014-09-20
10705031003026SURGICEL195219522014-09-20

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
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
00851772007281Emergency Medical ProductsEMERGENCY MEDICAL PRODUCTS, INC.LMG2016-09-24