FDA.reportPublic FDA data

Silicone Silo Bag

Primary DI
M746SSB750
Brand
Silicone Silo Bag
Company
SPECIALTY SURGICAL PRODUCTS INC
Model
SSB75
Catalog number
SSB75
Device description
Silicone Silo Bag For The Reduction of Abdominal Ventral Wall Defects
Published
2015-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973082000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973082000VENTRAL WALL DEFECT REDUCTION SILOSpecialty Surgical Products, Inc.1997-11-04FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M746SSB750PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy open-abdomen dressingA sterile dressing intended to be used on an open abdominal wall wound, with exposed viscera (e.g., abdominal compartment syndrome), to provide temporary wound bridging during negative-pressure wound therapy when primary closure is not possible and/or repeat abdominal entries are necessary. It typically consists of a nonadherent visceral protective layer, a perforated foam layer, an insulation layer to contain negative pressure, and tubing to connect to a negative-pressure wound therapy unit. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width7.5Centimeter

Contacts#

Phone, Email table
PhoneEmail
888-878-0811customerservice@ssp-inc.com

Regulatory Flags#

DUNS number
002112626
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M746SZ4681950Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 468 SPSZ468195SZ4681952018-06-01
M746SZ4682300Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 468 SPSZ468230SZ4682302018-06-01
M746SZ4682700Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 468 SPSZ468270SZ4682702018-06-01
M746SZ4683000Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 468 SPSZ468300SZ4683002018-06-01
M746SZ4683500Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 468 SPSZ468350SZ4683502018-06-01
M746SZ4683800Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 468 SPSZ468380SZ4683802018-06-01
M746SZ4684500Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 468 SPSZ468450SZ4684502018-06-01
M746SZ4684950Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 468 SPSZ468495SZ4684952018-06-01
M746SZ4685600Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 468 SPSZ468560SZ4685602018-06-01
M746SZ4686200Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 468 SPSZ468620SZ4686202018-06-01
M746RIPL0SSP Remote Injection PortRIP-LRIP-L2015-09-15
M746RIPS0SSP Remote Injection PortRIP-SRIP-S2015-09-15
M746PAD049Pediatric Anal DilatorPAD04PAD042022-07-18
M746PAD059Pediatric Anal DilatorPAD05PAD052022-07-18
M746PAD079Pediatric Anal DilatorPAD07PAD072022-07-18
M746PAD089Pediatric Anal DilatorPAD08PAD082022-07-18
M746PAD099Pediatric Anal DilatorPAD09PAD092022-07-18
M746PAD109Pediatric Anal DilatorPAD10PAD102022-07-18
M746PAD119Pediatric Anal DilatorPAD11PAD112022-07-18
M746PAD129Pediatric Anal DilatorPAD12PAD122022-07-18

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Primary DI, Brand, Company table
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