FDA.reportPublic FDA data

PlastiBell Circumcision Device

Primary DI
00840113231652
Brand
PlastiBell Circumcision Device
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
9234
Device description
1.4 cm PlastiBell Circumcision Device
Published
2023-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FHGBell, circumcision

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHGBell, CircumcisionObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840113231652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113231652008401132316528401132316520840113231652

GMDN Terms#

Term, Definition table
TermDefinition
Surgical penis clamp, single-useA sterile, hand-held manual surgical instrument designed to grasp the penis for manipulation during surgery (e.g., circumcision). It is typically a clip-like device e.g., with self-retaining levers. The penis is placed into this clamp that closes around or on the organ. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
027680821
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841785102714Symmetry Olsen20-1040I20-1040I2016-09-09
00841785102769Symmetry Olsen20-106020-10602016-09-06
00841785102776Symmetry Olsen20-1060I20-1060I2016-09-06
00841785102899Symmetry Olsen20-108020-10802016-09-06
00841785102905Symmetry Olsen20-1080I20-1080I2016-09-06
00841785102950Symmetry Olsen20-108220-10822016-09-06
00841785102967Symmetry Olsen20-1082I20-1082I2016-09-06
00841785102974Symmetry Olsen20-1082IMT20-1082IMT2016-09-07
00841785103025Symmetry Olsen20-109020-10902016-09-06
00841785103032Symmetry Olsen20-1090I20-1090I2016-09-06
00841785103049Symmetry Olsen20-1090IMT20-1090IMT2016-09-07
00841785103162Symmetry Olsen20-1162I20-1162I2016-09-06
00841785103285Symmetry Olsen20-1190I20-1190I2016-09-06
00841785103667Symmetry Olsen20-1325I20-1325I2016-09-08
00841785103674Symmetry Olsen20-1325IMT20-1325IMT2016-09-08
00841785103735Symmetry Olsen20-1330I20-1330I2016-09-08
00841785103742Symmetry Olsen20-1330IMT20-1330IMT2016-09-09
00841785103803Symmetry Olsen20-1340I20-1340I2016-09-06
00841785103865Symmetry Olsen20-1350I20-1350I2016-09-06
00841785103988Symmetry Olsen20-1360I20-1360I2016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840113231539PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231546PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231560PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231577PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231584PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231591PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231607PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231614PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231621PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231638PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231645PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231669PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
00840113231676PlastiBell Circumcision DeviceASPEN SURGICAL PRODUCTS, INC.FHG2023-02-27
10767056092171MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092300MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092324MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092331MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092348MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092355MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092379MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092157MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092317MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092102MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092119MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092126MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092133MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10767056092140MABIS DMID-M-S HOLDINGS, INC.FHG2016-09-23
10653160274766CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFHG2016-09-10
10653160274810CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFHG2016-09-10
10653160274759CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFHG2016-09-07