FDA.reportPublic FDA data

SWICKER

Primary DI
00850049993715
Brand
SWICKER
Company
Syntervention, Inc.
Model
4008-305
Catalog number
4008-305
Device description
The SWICKER is a sterile, highly absorbent medical accessory product intended for use in variety of surgical or medical procedures. Comprised primarily of a form of polyurethane, it has many uses including in areas such as open surgery, laparoscopic surgery, and wound care.
Published
2023-11-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GDYGauze/Sponge, Internal, X-Ray Detectable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850049993715PrimaryGS10
00850049993135Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049993715008500499937158500499937150850049993715
00850049993135008500499931358500499931350850049993135

GMDN Terms#

Term, Definition table
TermDefinition
Radiopaque non-woven surgical spongeA non-medicated device made from a non-woven absorbent material (e.g., rayon/polyester) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It is intended to produce less lint than woven gauze and contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0.25Inch
Length3Inch
Width3Inch

Regulatory Flags#

DUNS number
025315999
Device count
2
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850049993609SWICKER4008-2034008-2032023-11-09
00850049993623SWICKER4008-2054008-2052023-11-09
00850049993647SWICKER4008-2074008-2072023-11-08
00850049993661SWICKER4008-2094008-2092023-11-09
00850049993692SWICKER4008-3034008-3032023-11-09
00850049993739SWICKER4008-3074008-3072023-11-09
00850049993753SWICKER4008-3094008-3092023-11-09
00850049993784SWICKER4008-4034008-4032023-11-09
00850049993807SWICKER4008-4054008-4052023-11-09
00850049993821SWICKER4008-4074008-4072023-11-09
00850049993555SWICKER4007-4094007-4092023-11-09
00850049993562SWICKER401140112023-11-09
00850049993579SWICKER401340132023-11-09
00850049993029SWICKER4008-2034008-2032023-11-09
00850049993043SWICKER4008-2054008-2052023-11-09
00850049993081SWICKER4008-2094008-2092023-11-09
00850049993111SWICKER4008-3034008-3032023-11-09
00850049993135SWICKER4008-3054008-3052023-11-09
00850049993159SWICKER4008-3074008-3072023-11-09
00850049993173SWICKER4008-3094008-3092023-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956239692CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
07613327465853SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
10080196717811MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-04-25
10197106760994CARDINAL HEALTHCardinal Health 200, LLCGDY2025-01-29
10080196031313MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-01-16
10080196743926MEDLINEMEDLINE INDUSTRIES, INC.GDY2024-10-15
10326053119504Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119511Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119528Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119535Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119542Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119559Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119566Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119573Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119580Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
08600036785272USMEDCOUS MEDCO INCGDY2023-07-14
08600036785340USMEDCOUS MEDCO INCGDY2023-07-14
08600036785418USMEDCOUS MEDCO INCGDY2023-07-14
08600036785586USMEDCOUS MEDCO INCGDY2023-07-14
08600036785654USMEDCOUS MEDCO INCGDY2023-07-14
10197106046968CARDINAL HEALTHCardinal Health 200, LLCGDY2023-07-12
10192253050288KerlixCardinal Health 200, LLCGDY2023-03-24
10665973000012DukalDukal LLCGDY2022-12-06
10665973000029DukalDukal LLCGDY2022-12-06
10665973000036DukalDukal LLCGDY2022-12-06
10665973000050DukalDukal LLCGDY2022-12-06
10665973000067DukalDukal LLCGDY2022-12-06
10665973000081DukalDukal LLCGDY2022-12-06
10665973000098DukalDukal LLCGDY2022-12-06
10665973000166DukalDukal LLCGDY2022-12-06