FDA.reportPublic FDA data

Silicone Silo Bag Sizer Ring

Primary DI
M746SSBSR400
Brand
Silicone Silo Bag Sizer Ring
Company
SPECIALTY SURGICAL PRODUCTS INC
Model
SSB-SR-40
Catalog number
SSB-SR-40
Device description
Silicone Silo Bag Sizer Ring For Use with the SSP Silicone Silo Bag
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
M746SSBSR400PrimaryHIBCC0

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
Width4Centimeter

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
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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
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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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