FDA.reportPublic FDA data

Seraket Tourniquets

Primary DI
10818087010822
Brand
Seraket Tourniquets
Company
PROPPER MANUFACTURING COMPANY, INC.
Model
22712000
Catalog number
22712000
Device description
Seraket Tourniquet - Case of 120
Published
2023-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
70818087010824PrimaryGS10
10818087010822Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7081808701082470818087010824
1081808701082210818087010822

GMDN Terms#

Term, Definition table
TermDefinition
Limb tourniquet, manual, reusableA strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling. It will typically have a fastening mechanism (e.g., Velcro or a self-locking buckle) that allows adjustments to the degree of tightness. This is a reusable device which may be intended for single- or multi-patient use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001483130
Device count
120
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
30818087011618Propper Vapor Line Integrators26900921269009212026-07-16
30818087011960Propper Gas-Chex Indicator Strips26900100269001002017-10-04
70818087011623Macintosh #1 Disposable Laryngoscope Blade19924100199241002026-05-15
70818087011630Macintosh #2 Disposable Laryngoscope Blade19924200199242002026-05-15
70818087011647Macintosh #3 Disposable Laryngoscope Blade19924300199243002026-05-15
70818087011814Macintosh #4 Disposable Laryngoscope Blade19924400199244002026-05-15
70818087011821Miller #0 Disposable Laryngoscope Blade19934000199340002026-05-15
70818087012040Miller #2 Disposable Laryngoscope Blade19934200199342002026-05-15
70818087012156Miller #3 Disposable Laryngoscope Blade19934300199343002026-05-15
70818087012163Miller #4 Disposable Laryngoscope Blade19934400199344002026-05-15
70818087013214Miller #1 Disposable Laryngoscope Blade19934100199341002026-05-15
30818087010918"Verline Steam Autoclave Indicator Tape 1/2"" x 14 YD - 24/pack"26814400268144002023-06-16
30818087010932"Verline Steam Autoclave Indicator Tape 3/4"" x 14 YD - 16/pack"26814500268145002023-06-16
30818087010949"Verline Steam Autoclave Indicator Tape 1"" x 14 YD - 12/pack"26814600268146002023-06-16
30818087012271"Propper 9/16"" Steri-Dot Process Indicator"36100100361001002021-09-12
30818087012325"Propper 1"" Steri-Dot Process Indicator"36100200361002002021-09-12
30818087012400"Propper 3/4"" Steam Dot Process Indicator"36400100364001002021-09-12
70818087010343"Propper Verline Indicator Tape 1/2"" x 14 YDS"26824416268244162022-10-20
70818087010367"Propper 3/4"" Steri-Dot Process Indicator Bulk Pack (110 RL/CS)"36100801361008012022-10-28
70818087010732"Propper Verline 1/2"" Steam Autoclave Tape Mini-Rolls"26814416268144162023-02-23

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