FDA.reportPublic FDA data

SWICKER

Primary DI
00850049993029
Brand
SWICKER
Company
Syntervention, Inc.
Model
4008-203
Catalog number
4008-203
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00850049993609PrimaryGS10
00850049993029Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049993609008500499936098500499936090850049993609
00850049993029008500499930298500499930290850049993029

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
Height0.125Inch
Length1.5Inch
Width3Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
025315999
Device count
2
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
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
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
00850049993715SWICKER4008-3054008-3052023-11-09
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
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