FDA.reportPublic FDA data

PerClot

Primary DI
05413765891373
Brand
PerClot
Company
BAXTER HEALTHCARE CORPORATION
Model
PCUS005
Catalog number
PCUS005
Device description
PerClot 5g - 9cm Standard Tip
Published
2023-06-23
Public version status
New
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
P210036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P210036000PerClot® Polysaccharide Hemostatic SystemBaxter Healthcare Corporation2023-05-19LMG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05413765891373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05413765891373054137658913735413765891373

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)422-9837US-MEDINFO_MEDPRODUCTS@baxter.com

Regulatory Flags#

DUNS number
005083209
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412003252Aviva/Viaflex2B80662B80662016-09-24
00085412036311Baxter2C62502C62502016-09-24
00085412600024DUPLOCATH150616515061652018-09-28
00085412600031DUPLOCATH150616615061662018-09-28
00085412600048DUPLOCATH150616715061672018-09-28
00085412002576INTERLINK2C74512C74512016-09-24
00085412002583INTERLINK/DUO-VENT2C74522C74522016-09-24
00085412004976INTERLINK2N33952N33952016-09-24
00085412046334CLEARLINK2C86712C86712016-09-24
00085412046433CLEARLINK2H86032H86032016-09-24
00085412048963CLEARLINK2C86102C86102016-09-24
00085412049007CLEARLINK2C86322C86322016-09-24
00085412049014CLEARLINK2C86062C86062016-09-24
00085412051727CLEARLINK1C86931C86932016-09-24
00085412070056CLEARLINK2C86122C86122016-09-24
00085412071671CLEARLINK2C86072C86072016-09-24
00085412071718CLEARLINK2C89212C89212016-09-24
00085412080949CLEARLINK2H86312H86312016-09-24
00085412080956CLEARLINK2H86712H86712016-09-24
00085412000046INTRAVIA2B80142B80142016-09-24

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