FDA.report

ELMED

Primary DI
00842180163768
Brand
ELMED
Company
ELMED INCORPORATED
Model
31-1450-008
Catalog number
31-1450-008
Device description
PRATT Uterine Dilators. Solid, double-ended. Mirror finish. Overall length 11-3/8in (28.9cm). Size 41-43Fr
Published
2023-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HDQDilator, Cervical, Fixed Size
HDXDilator, Vaginal

Product Code Classifications

CodeDeviceSpecialtyClass
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1
HDXDilator, VaginalObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180163768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180163768008421801637688421801637680842180163768

GMDN Terms

TermDefinition
Pulmonary dilatorA surgical instrument used during a surgical procedure to enlarge or open/clear a pulmonary structure. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags

DUNS number
049290364
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00198506089770ELMED INCORPORATED52460-02-H52460-02-H2026-03-24
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00198506089756ELMED INCORPORATED42-191042-19102026-03-23

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