FDA.report

Natrelle 410 Resterilizable Sizers

Primary DI
10888628005174
Brand
Natrelle 410 Resterilizable Sizers
Company
Allergan, Inc.
Model
MSZLF270
Catalog number
MSZLF270
Device description
NATRELLE 410 Rester Szr Sty MSZ-LF270
Published
2015-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MRDSizer, Mammary, Breast Implant Volume

Product Code Classifications

CodeDeviceSpecialtyClass
MRDMammary SizerUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10888628005174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088862800517410888628005174

GMDN Terms

TermDefinition
Invasive breast implant sizer, single-useA sterile surgical instrument intended to be placed intraoperatively in a surgically-prepared mammary pocket to provide a volume measurement for the appropriate selection of a breast implant (mammary prosthesis). The device consists of a balloon-like elastomer shell that is either filled to an optimal volume via tubing and port, or is prefilled with a fixed amount of silicone gel. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Dry Heat Sterilization

Contacts

PhoneEmail
8006244261ProductSupport@allergan.com

Regulatory Flags

DUNS number
144796497
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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30840228302781JUVEDERM ULTRA XC 1ML SAMPLE94154DB94154DB2024-04-10
30840228302798JUVEDERM VOLBELLA XC 1ML SAMPLE96181DB96181DB2024-04-10
30840228302804JUVEDERM VOLBELLA XC 0.55ML SAMPLE96183DB96183DB2024-04-10
30840228302811JUVEDERM VOLLURE XC 1ML SAMPLE95661DB95661DB2024-04-10
30840228302828JUVEDERM VOLUMA XC 1ML SAMPLE94640DB94640DB2024-04-10
30840228302835JUVEDERM VOLUX XC 1ML SAMPLE20074128200741282024-04-10
30840228300060Skinvive98307983072023-05-22
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10888628005945NATRELLE Resterilizable Breast Implant SizersMSZ20200MSZ202002022-10-23
10888628005952NATRELLE Resterilizable Breast Implant SizersMSZ20230MSZ202302022-10-23
10888628005969NATRELLE Resterilizable Breast Implant SizersMSZ20260MSZ202602022-10-23
10888628005976NATRELLE Resterilizable Breast Implant SizersMSZ20280MSZ202802022-10-23
10888628005983NATRELLE Resterilizable Breast Implant SizersMSZ20300MSZ203002022-10-23
10888628005990NATRELLE Resterilizable Breast Implant SizersMSZ20325MSZ203252022-10-23
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