FDA.reportPublic FDA data

Pediatric Anal Dilator

Primary DI
M746PAD109
Brand
Pediatric Anal Dilator
Company
SPECIALTY SURGICAL PRODUCTS INC
Model
PAD10
Catalog number
PAD10
Device description
Pediatric Anal Dilator, 10mm Size, Single Patient-Multiple Use, Non-Sterile
Published
2022-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFPDilator, Rectal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFPDilator, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M746PAD109PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rectal dilator, single-useA sterile surgical instrument designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002112626
Device count
1
Premarket exempt
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
M746PAD119Pediatric Anal DilatorPAD11PAD112022-07-18
M746PAD129Pediatric Anal DilatorPAD12PAD122022-07-18
M746PAD139Pediatric Anal DilatorPAD13PAD132022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850005838449Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838456Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838463Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838487Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838494Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838500Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838517Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838524Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838531Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838548Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838555Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
G586UR6213360Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR6214120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR6214140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214130Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
00842331194603Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6216100Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6216160Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217130Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217150Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217210Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217220Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217230Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217240Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
08033638801147DilastomSAPI MED SPAFFP2023-08-02
08033638803929DilastomSAPI MED SPAFFP2023-08-02