FDA.report

SWICKER

Primary DI
00850049993241
Brand
SWICKER
Company
Syntervention, Inc.
Model
4008-407
Catalog number
4008-407
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

Related Records

Product Codes

CodeName
GDYGauze/Sponge, Internal, X-Ray Detectable

Product Code Classifications

CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850049993821PrimaryGS10
00850049993241Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850049993821008500499938218500499938210850049993821
00850049993241008500499932418500499932410850049993241

GMDN Terms

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

TypeValueUnit
Height0.5Inch
Length5Inch
Width5Inch

Sterilization Methods

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 DIBrandModelCatalogPublished
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
00850049993203SWICKER4008-4034008-4032023-11-09
00850049993227SWICKER4008-4054008-4052023-11-09
00850049993067SWICKER4008-2074008-2072023-11-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50192253050293VistecCardinal Health 200, LLCGDY2026-03-05
10815555025678CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025685CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025661CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025630CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025623CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025647CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025654CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
50198956239690CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
10850049994863Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994870Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994887Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994894Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994900Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994917Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994924Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994931Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994948Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994955Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994962Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994979SynterventionZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994993Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-23
10850049994986Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-22
37613327465854SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
06979032640079GOBENHUZHOU JUNDA INDUSTRY CO., LTD.GDY2025-08-26
30193489015991MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-12
40888277338914MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079747MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079754MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079822MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06